GMK Sphere Total Knee System 02.12.0312FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 07630030826382), received between Sep 21, 2018 and Jul 21, 2025 — classified as 28 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 MONTHS FROM THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE LINER (12 MM) WITH A THICKER ONE (14MM) TO GIVE MORE STABILITY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22554193 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD KNEE INSTABILITY, DUE TO LAXITY. AT ABOUT 1 YEAR AND 2 MONTHS POST PRIMARY THE SURGEON REVISED THE 12MM POLY TO A 14MM POLY AND RESURFACED THE NATIVE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20036066 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD ANTERIOR KNEE PAIN AND MILD INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 5 YEARS AND 11 MONTHS POST PRIMARY THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND UPSIZED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19711183 ↗
• InjuryDec 19, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT 3 YEARS AND 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO HYPEREXTENSION OF THE KNEE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE 12MM INSERT WITH A 17MM INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18354756 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 YEARS AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE 12MM POLY TO A 20MM POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18267222 ↗
• InjuryOct 26, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE PATELLA AND THE CAUSE OF THE LOOSE PATELLA IS UNKNOWN. ABOUT 3 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE PATELLA AND UPSIZED THE POLY (DUE TO INSTABILITY), AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18011665 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS AND 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON RESURFACED THE NATURAL PATELLA AND REVISED THE INSERT (12MM) WITH A THICKER ONE (14MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17265028 ↗
• InjuryMay 9, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 1 YEAR AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING STIFFNESS AND LACK OF MOTION DUE TO THE FORMATION OF EXCESSIVE SCAR TISSUE. THE SURGEON REMOVED SCAR TISSUE AND REVISED THE INSERT (SAME THICKNESS OF 12MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 16893759 ↗
• InjuryMar 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS FROM PRIMARY THE SURGEON REVISED THE PATIENT LINER FOR KNEE INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16466504 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (12 TO 17MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15735263 ↗
• InjuryJul 6, 2022Appropriate Device Problem Term/Code Not Available

  AT ABOUT 3 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14927436 ↗
• InjuryMay 3, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT 10 MONTHS POST PRIMARY THE SURGEON REVISED THE INSERT (NEW ONE IS 17MM HIGH) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 14267053 ↗
• InjuryApr 6, 2022Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT WITH A HIGHER ONE 9 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 14021281 ↗
• InjuryMar 1, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. ABOUT 2 YEARS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE INSERT WITH A THICKER ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 13634690 ↗
• InjuryMay 28, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  AFTER THE PRIMARY KNEE SURGERY (THE SAME DAY), IN POST-OP RECOVERY, IT WAS OBSERVED THAT THE PATIENT DISLOCATED ANTERIORLY FROM THE TIBIA (FEMUR FROM INSERT). THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 11899533 ↗
• InjuryFeb 24, 2021Insufficient Device Problem Information

  THE PATIENT CAME IN REPORTING INSTABILITY 4 MONTHS AFTER THE PRIMARY. THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE TIBIAL INSERT FIXED SPHERE FLEX #3/12 MM R WITH A GMK-SPHERE TIBIAL INSERT - FLEX S3R - 17MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11372362 ↗
• InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, 2 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO A QUAD TENDON RUPTURE. THE CAUSE OF THE QUAD TENDON RUPTURE IS UNKNOWN. THE SURGEON PERFORMED A QUAD TENDON REPAIR AND REVISED THE GMK-SPHERE TIBIAL INSERT - FLEX S3R - 12MM WITH A GMK-SPHERE TIBIAL INSERT - FLEX S3R - 12MN. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 11036667 ↗
• InjuryDec 17, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD PAIN AND THE KNEE WASN'T STABLE, THEREFORE, THE SURGEON DECIDED TO CHANGE TO A THICKER INLAY AND PUT A PATELLA (3 YEARS AND 10 MONTHS AFTER PRIMARY SURGERY).

  Patient problems: Joint Laxity

  MAUDE report 11025983 ↗
• InjuryOct 16, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 6 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10689370 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem

  ANTERIOR KNEE PAIN AND INSTABILITY. PATIENT'S PATELLA HAS BEEN RESURFACED AND A HIGHER LINER (14 MM) HAS BEEN IMPLANTED 2 YEARS AND 9 MONTHS AFTER PRIMARY.

  Patient problems: Balance Problems; Pain

  MAUDE report 10579078 ↗
• InjurySep 1, 2020Appropriate Device Problem Term/Code Not Available

  DUE TO PAIN AND INSTABILITY THE PATIENT WAS OPERATED TO CHANGE THE INLAY AND TO RESURFACE THE PATELLA, 8 MONTHS AFTER PRIMARY SURGERY. THE PATELLA IMPLANTED WAS FROM COMPETITOR, INLAY CHANGED FROM 12MM TO 14MM.

  Patient problems: Joint Disorder

  MAUDE report 10475976 ↗
• InjuryJun 2, 2020Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY. THE SURGEON REVISED THE 12MM POLY WITH A 17MM POLY ALMOST 1 YEAR AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10108748 ↗
• InjuryApr 1, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2017. ON (B)(6) 2019, THE POLY WAS REVISED BECAUSE OF AN INFECTION. PRESENTLY, ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL HARDWARE AND PROCEEDED TO IMPLANT AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9909609 ↗
• InjuryMar 24, 2020Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING DISCOMFORT DUE TO LAXITY IN THE KNEE 5 MONTHS AFTER PRIMARY. THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE MEDACTA SPHERE INSERT FLEX RIGHT 12MM S3 WITH A MEDACTA SPHERE INSERT FLEX RIGHT 17MM S3. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9872421 ↗
• InjuryAug 21, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 2 YEARS AFTER PRIMARY THE SURGEON PERFORMED AN ARTHROSCOPY AND OPEN SYNOVECTOMY AND DECIDED TO REPLACE THE 12MM TIBIAL INSERT. THE INSERT WAS REPLACED WITH A 13MM ONE AT THIS TIME. THE SURGEON NOTED THAT THE EXPLANTED INSERT WAS IN GOOD CONDITION. AS PER VERBAL NOTIFICATION THE REASON OF PAIN IS UNKNOWN AND THERE WAS NO KNEE INSTABILITY.

  Patient problems: Pain

  MAUDE report 8914445 ↗